21 CFR 58.81: Standard operating procedures
Requires testing facilities to maintain written, management-approved SOPs covering key study activities, document study director-authorized deviations in raw data, keep SOPs available in lab areas, and retain a historical file of revisions.
Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies · Subpart E, Testing Facilities Operation
Recent 483s citing 58.81
- BASF Corporation · East Setauket, New YorkNot all deviations from standard operating procedures in a study were authorized by… May 29, 2025
- Forest/Inwood Laboratories, Inc. · Farmingdale, New YorkThe SOP #F-001 entitied "Analytical Run Acceptance Criteria” is not objective in… Oct 23, 1998
The regulation text
§ 58.81 Standard operating procedures.
(a)A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
(b)Standard operating procedures shall be established for, but not limited to, the following:
(1)Animal room preparation.
(2)Animal care.
(3)Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles.
(4)Test system observations.
(5)Laboratory tests.
(6)Handling of animals found moribund or dead during study.
(7)Necropsy of animals or postmortem examination of animals.
(8)Collection and identification of specimens.
(9)Histopathology.
(10)Data handling, storage, and retrieval.
(11)Maintenance and calibration of equipment.
(12)Transfer, proper placement, and identification of animals.
(c)Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d)A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
Questions
What does 21 CFR 58.81 require?
Requires testing facilities to maintain written, management-approved SOPs covering key study activities, document study director-authorized deviations in raw data, keep SOPs available in lab areas, and retain a historical file of revisions.
Which sections are cited alongside 58.81?
In the same 483s, investigators most often also cite 58.63 (Maintenance and calibration of equipment), 58.190 (Storage and retrieval of records and data), 58.33 (Study director), 58.35 (Quality assurance unit).